Back To: Home

CLICK HERE FOR WHAT'S NEW IN:
 




 

Proteon adjusts PATENCY-2 trial
May 2017
SHARING OPTIONS:

WALTHAM, Mass.—As the first quarter ended, Proteon Therapeutics Inc. shared its financial results for full-year 2016, as well as an update on its PATENCY-2 trial for vonapanitase. This trial is the second Phase 3 clinical study of the investigational drug, with results from the first Phase 3 trial released in December 2016. After reviewing data from that trial, Proteon entered discussions with the FDA regarding protocol for PATENCY-2, and made several changes, including reordering the trial endpoints by making secondary patency and fistula use for hemodialysis co-primary endpoints and increasing planned enrollment from 300 to 500 patients. In addition, given the talks with the FDA, Proteon feels that, pending statistical significance in PATENCY-2 for each co-primary endpoint, the PATENCY-2 data and data from other completed studies could form the basis for a Biologics License Application and remove the need for additional studies.

Back



PAGE UTILITIES


CONTACT US
DDNEWS
Published by Old River Publications LLC
19035 Old Detroit Road
Rocky River, OH USA 44116
Ph: 440-331-6600  |  Fax: 440-331-7563
 
© Copyright 2017 Old River Publications LLC. All righs reserved.  |  Web site managed and designed by OffWhite.